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Gifts For Industry: From Waived Inspections To Pre-Market Leeway, US FDA Woos Firms For Maturity Pilot

FDA wants to give away a basket of goodies to manufacturers that voluntarily play in an upcoming pilot program that will help the agency determine the manufacturing maturity of device-makers by using the CMMI maturity model appraisal process. Incentives to join the pilot include FDA delaying regularly scheduled facility audits, waiving preapproval inspections, allowing more leeway for 30-day notices and pre-market submissions, and easing up on the issuance of FDA warning letters. A major goal of the initiative is for the agency to have greater confidence in firms that demonstrate high-quality, gold-star quality systems so it can focus its limited resources on less mature, troublesome firms.

Quality Control Compliance FDA

45% Leap In Notified-Body Certificates Withdrawn From Device Firms

2016 saw the largest single-year rise in the number of EU certificates that were withdrawn from device companies by members of the TEAM-NB notified body association. The specific causes of the withdrawals varied, but increased regulatory expectations in the EU are likely an important factor.

Medical Device Europe Regulation

Pain Management I: Spinal-Cord Stim To Grab Ever-Bigger Market Share

The field of neuromodulation for treating chronic pain is growing rapidly, especially in the fastest-growing spinal cord stimulation (SCS) market segment, which is expected to hit $2.4bn by 2021. This article, the first of a two-part series, will explore what the key drivers and limitations are for the SCS market and provide insight from three established pain management specialists on what factors will push wider adoption of this therapy.

Neurology Market Intelligence Commercial

Starts & Stops: New Trial Starts Led By Peripheral Vascular Interventions

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions the past month or so. Over the last month, 38 new trials started, 17 trial were completed, one trial was "reinitiated," and four trials were terminated or suspended, according to Meddevicetracker.

Clinical Trials Starts & Stops Research & Development
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Podcast: Nadim Yared Hits The Ground Running As AdvaMed Chair

In a podcast interview to discuss his initial experience as chairman of AdvaMed, CVRx CEO Nadim Yared talks about the group's laser focus on device-tax repeal, irrespective of broader GOP health-care debates and controversy, its capacity to handle unpredictability and change in Washington, DC, and more.

Leadership Legislation Digital Health

Trump Budget: 71% Of US FDA Device Funding Would Come From User Fees

The Trump White House is not backing down in its push to renegotiate the US FDA user-fee reauthorization deals that were inked during the Obama administration. The FY 2018 budget request would ask for more than a $200m increase in fees from device companies in the coming fiscal year to counterbalance major cuts in appropriations from Congress. That would make the agency's device program dependent on user fees for about 71% of its budget, versus about 27% currently. But Congress has already said it opposes the plan.

Legislation United States Medical Device

US FDA's Gottlieb Wants Safety Built Into New Medtech Products, But Budget Will Be Cut To Surveil Older Ones

President Trump's proposed budget cuts to the agency's post-market surveillance programs means that more "faulty" devices, such as St. Jude defibrillators and Bayer HealthCare's Essure birth control coils, will cause harm rather than be recalled, Rep. Rosa DeLauro said at a May 25 House Ag/FDA subpanel hearing. FDA Commissioner Scott Gottlieb told DeLauro the agency needs to supply "the right tools" to firms during device development so similarly flawed devices aren't put on the market, and he noted that the lifting of a hiring freeze at the agency earlier in the day would free the agency to work harder on such issues.

Policy & Regulation Legislation

European Commission Makes Final Decision On Cranberry Products

Several manufacturers in the EU have marketed cranberry capsules as medical devices to gain regulatory and marketing advantages. Others have lobbied against this "unfair practice." France took the matter to the European Commission, which took action – the first time the commission employed its "borderline"-product designation authority.

Medical Device Europe

Warning Letter Roundup & Recap – May 23, 2017

US FDA did not release any device-related warning letters the week of May 23.

Medical Device Device Warning Letters

Abbott Catheter Recall Designated As Class I

A tight balloon sheath in some Abbott coronary catheters has been linked to adverse events including air embolism, thrombosis, heart attack and death. Almost 450,000 units are being recalled worldwide.

Recalls Safety

TGA Consults On Ground Rules For Identifying ‘Comparable’ Regulators To Reduce Duplication

Australia has proposed criteria against which it plans to evaluate overseas regulators to ascertain if their standards are comparable, and whether their assessment reports can be used to support inclusion of medical devices on the Australian Register of Therapeutic Goods. Also, there are plans to develop work-sharing arrangements with comparable regulators on a case-by-case basis.

Regulation Australia

Senators To Trump Administration: 'Way Too Late' To Change US FDA Budget Structure Now

Senate HELP Committee leaders Lamar Alexander, R-Tenn., and Patty Murray, D-Wash., said it's "way too late" for Congress to alter the budgetary balance between device and drug industry US FDA user-fee contributions and congressional appropriations for the upcoming 2018-2022 user-fee cycle in tersely worded statements to HHS Secretary Tom Price May 16.

Legislation Medical Device

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Latest From Quality Control

Q1 Recalls Snapshot: Recalled Device Units Drop To Lowest Level Since 2013; Recall Events Dip Slightly

There were 284 recall events from January through March, down 9% from Q4 2016's 313 corrections and removals. Check out our Q1 recalls infographic.

Recalls Quality Control

More Review-Streamliners Introduced In US House: Can They Beat User-Fee Buzzer?

Two more bills were introduced in the House this week to streamline US FDA device review. Its late in the game, but device lobbyists are not completely ruling out attachments to must-pass user-fee bills. Also, check out our table rounding up FDA medtech reform bills that are circulating in Congress.

Legislation Policy

Singapore Consults On Implementing New Device Distribution Standard

Singapore’s Health Sciences Authority is inviting feedback on a draft guideline to help medical device importers and wholesalers comply with its new standard on good distribution practice. The earlier technical specification on this topic will be phased out by 2020.

Regulation Quality Control

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Pain Management II: Competition Intensifies For Spinal Cord Stim Market's Big Three

In the global pain management market, spinal cord stimulation (SCS) systems are expected to continue to be the fastest-growing segment with increasing competition among device manufacturers to develop innovative, targeted therapies. In this second article of a two-part series, we'll discuss the competitive landscape in the SCS market, the key players, emerging companies and their respective technologies.

Neurology Market Intelligence Commercial

Latest From Commercial

Qualcomm: A New Kind Of Medical Device Company

The mobile-technology company is trying to corner the wireless needs of the health-care industry, and is pushing for adoption of value-based health-care models that would be dependent on more data-sharing to justify costs based on patient outcomes.

Business Strategies Clinical Trials

Medtronic Hits Targets In "Solid" Fiscal 2017

Medtronic, medtech's number one player, did not disappoint the market with its final fiscal quarter performance. With revenue and profit figures exceeding analysts' expectations, the group's outlook for fiscal 2018 is also looking equally positive.

Sales & Earnings Companies

IVD UK Spring Meeting: Diagnostics Get New Market Access Tools – But At A Price

First of two articles covering discussion at the spring 2017 meeting of the British In Vitro Diagnostics Association: The UK IVD companies are soon to get new tools designed to make market access for innovations easier and more predictable. This is welcome news, given the backdrop of Brexit and the costly route to compliance to the new EU IVD Regulation compliance.

United Kingdom Commercial

New Acquisition And Positive Data Inflates Philips' Respiratory Biz

Philips has expanded its sleep and respiratory care unit with the acquisition of US firm Respiratory Technologies, Inc., which offers a noninvasive airway clearance solution for patients with chronic respiratory problems. Separately, as an additional boost to this business, a clinical study sponsored by the Dutch multinational gave further support for the combined used of home noninvasive ventilation with oxygen therapy to delay hospital readmissions in COPD patients.

Respiratory M & A

Device Week – May 19, 2017

On this week's Medtech Insight podcast: ex-US FDA Commissioner Bob Califf talks new commish and Trump; the latest on the Food and Drug Administration Reauthorization Act (FDARA); FDA recommends approval for the TransMedics Organ Care System; blood lead tests made by Magellan Diagnostics may give bad results; updates from the Heart Rhythm Society Scientific Sessions in Chicago and EuroPCR 2017 in France.

FDA Medical Device

vitalityDNA Plans To Keep Healthy People Healthy

vitalityDNA is taking the preventative approach to health care with its personalized health and lifestyle plan offering. The start-up will initially target consumers and then health care companies.

In Vitro Diagnostics StartUps and SMEs

Clinical R&D Explore this Topic

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EuroPCR 2017: TAVR Continues To Beat Surgery; Bioabsorbable Stents Not Going Away

The EuroPCR conference in Paris is the most important annual interventional cardiology conference in Europe and this year's edition brought more data from clinical trials of both established catheter-based technologies and innovative new devices.

Cardiology Clinical Trials Innovation

Latest From Research & Development

Blue Earth Extends Global PET Reach With EU Approval

Blue Earth Diagnostics, a molecular imaging agent specialist spun out of GE Healthcare, has secured EU approval to market its PET tracer for detecting recurrent prostate cancer. Axumin, which was approved in the US a year ago, is said to be only PET imaging agent for this indication in the EU.

Diagnostic Imaging Cancer

New Acquisition And Positive Data Inflates Philips' Respiratory Biz

Philips has expanded its sleep and respiratory care unit with the acquisition of US firm Respiratory Technologies, Inc., which offers a noninvasive airway clearance solution for patients with chronic respiratory problems. Separately, as an additional boost to this business, a clinical study sponsored by the Dutch multinational gave further support for the combined used of home noninvasive ventilation with oxygen therapy to delay hospital readmissions in COPD patients.

Respiratory M & A

INS 2017 Aims To Offer Sneak Peek Into Future Neuromodulation Trends

As scientific and industry experts prepare to gather in Edinburgh, Scotland, later this month for the 13th International Neuromodulation Society Congress, Medtech Insight spoke to Timothy Deer, INS president and a pain-management specialist, about what's ahead in neuromodulation and what to expect at the meeting.

Research & Development Innovation

HRS 2017: EBR's Leadless CRT Feasibility; Watchman Registry Data; A Novel AF Ablation Catheter From BW; And More Medtronic CRT Data

Results from "real-world" registries of established devices, along with encouraging early results from novel devices were among the highlights of Heart Rhythm 2017, the annual scientific sessions of the Heart Rhythm Society, held in Chicago May 10-13.

Cardiology Clinical Trials

EuroPCR 2017: Xeltis' Regenerated Heart Valve Shows Promising Early Preclinical Data

It may still be early days but Xeltis' second product from its Endogenous Tissue Restoration platform technology, an aortic valve scaffold, is showing promising results in animal studies. The data, presented at EuroPCR, showed that the bioresorbable aortic valve had good hemodynamic performance and fully functional valves in vivo six months after implantation.

StartUps and SMEs Research & Development

EuroPCR 2017: Boston Scientific's Lotus TAVR Beats Medtronic's CoreValve In REPRISE III, But Pacemaker Issue Remains

Boston Scientific's repositionable, mechanically expanded Lotus transcatheter aortic valve performed better than Medtronic's CoreValve for the primary composite effectiveness endpoint in the REPRISE III trial, according to results presented at the EuroPCR meeting in Paris. But the Lotus patients in the trial were more likely to need a pacemaker than the CoreValve patients, a risk that investigators believe can be mitigated with better operator technique.

Cardiology Clinical Trials
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